UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C. 20460
July 20, 1988
The Honorable Lee M. Thomas . THe ^"'
Administrator
U.S. Environmental Protection Agency
401 M. Street, s.W.
Washington, O.C. 20460
Dear Mr. Thomas:
The Water Quality Advisories Subcommittee of the Science
Advisory Board's Environmental Effects, Transport and Fate
Committee has completed its review of the office of Water's
guidelines for preparing water quality advisories. !The review
was requested by Edmund M. Notzon, Director of the Criteria and
Standards Division of the Office of Water and the review was
conducted on October 22 and 23, in Annapolis, Maryland.
The Subcommittee recognizes the potential that, the advisory
concept provides for bringing a greater number of pollutants
under regulatory control in a relatively short period of time.
The concept represents a preliminary step towards water quality
criteria development and is designed to protect both ambient
aquatic life and human health. The primary issue regarding
ambient aquatic life protection involves defining and obtaining a
minimum data base for advisory development. Data describing
interactions in aquatic systems have not been developed for many
pollutants. Data are more prevalent for characterizing human
health risks, and obtaining a minimum data base is not of
concern. Instead, the primary issue for human health protection vxa
advisories is the appropriate depth of review of the existing
data base.
In general, the Subcommittee has more support for the
concept as it applies to ambient aquatic life protection than
for application to human health protection, based on availability
of data. Subcommittee cautions that advisories should not
substitute for water quality criteria and recommends that a
mechanism for advancing advisories to criteria status be
specified to insure that emerging data are enfolded to reduce
uncertainty, in addition, the Subcommittee feels that it is
imperative that a review process and public comment period be
incorporated to balance the increased uncertainty inherent in the
advisory process.
Regarding advisories for the protection of ambient aquatic
life, an approach which the Subcommittee endorses, some
suggestions for improving the guideline documents and the process
-------
Page 2
in general ar* provided. These suggestions includes specifying
the'data ftMttod, to advance understanding of the toxicity of the
pollutant aHressed, documenting uncertainty factors, employing
quality ratings, and including modifications to address exposure
duration, site-specific issues, and sensitive species rather than
those that are commercially or recreationally important.
To guide decisions about human health, the Subcommittee
prefers the use of the water quality criteria process, and has
reservations with applying the advisory concept. Particular
opposition is directed toward the restriction of literature
searching to the most recent 5 years, and to the use of secondary
literature sources. The risk assessment procedure described in
the guideline documents focuses on data presentation rather than
on analysis, and the use of modifying factors cannot be endorsed.
Most of the Subcommittee's criticism is related to the- error that
results in assuming that a short risk assessment is easier,
quicker and less expensive than a long one. In fact a properly
prepared, concise advisory could take less paper, but require the
same level of effort required for a criteria document.
The Subcommittee appreciates the opportunity to conduct this
scientific review. We request that the Agency formally respond
to the scientific advice transmitted in the attached report.
Sincerely
I
Norton Nelson, Chairman
Executive Committee
Science Adyisorv Board
rtung,
Environmental Effects,
Transport and Fate
-U
Kenneth Dickson, Chairman
Water Quality Advisories
Subcommittee
Enclosure
cc: A. James Barnes
Lawrence Jensen
J, Michael Conlon
Edmund Notzon
Frank Gostomski
Donald Barnes
-------
United States Office of the Administrator ' 3A5-EET&FO-88-032
Environmental Protection Science Advisory Board ^ly, 1988
Agency Washington, D.C. 20460 Final Report
'*• Report of the Environmental
Effects, Transport and Fate
Committee
Review of the Guidelines
for Preparing
Water Quality Advisories
-------
U.S. ENYIRONMSNTAL PROTECTION AGENCY
NOTICE
This report has been written as a part of the activities of
the Science Advisory Board, a public advisory group providing
extramural scientific information and advice to the Administrator
and other officials of the Environmental Protection Agency. The
Board is structured to provide a balanced expert assessment of
scientific matters related to problems facing the Agency. This
report has not been reviewed for approval by the Agency; and,
hence, the contents of this report do not necessarily represent
the views and policies of the Environmental Protection Agency or
other agencies in Federal government. Mention of trade names or
commercial products does not constitute a recommendation for use.
-------
U.S. ENVIRONMENTAL PROTECTION AGENCY
SCIENCE ADVISORY BOARD
ENVIRONMENTAL EFFECTS, TRANSPORT AND FATE COMMITTEE
WATER QUALITY ADVISORIES SUBCOMMITTEE
ROSTER
chair
Dr. Kenneth Dickson
Institute of Applied Sciences
North Texas State University
P.O. BOX 13078
Denton, Texas 76203
Vice Chairman
Dr. Rolf Hartung
Professor of Environmental Toxicology-
School of Public Health
University of Michigan
Ann Arbor, Michigan 48109
Members
Dr. Ira Adelman
Department of Fisheries and Wildlife
University of Minnesota Twin Cities
1980 Folwell Avenue
St. Paul, Minnesota 55108
Dr. Herb Cornish
Professor Emeritus
University of Michigan
830 West Clark Road
Ypsilanti, Michigan 48198
Dr. Patrick Durkin
Syracuse Research Corporation
Merrill Lane
Syracuse, New York 13210-4080
Dr. Ron Jarman
ERT
12655 North Central Expressway
Suite 706
Dallas, Texas 75243
Dr. Richard Kimerle
Monsanto Corporation
800 N. Lindbergh Boulevard
St. Louis, Missouri 63167-5842
ii
-------
Dr» Dan Menzel
Director and Professor
Pharmacology and Medicine
Director
Cancer Toxicology and Carcinogenesis Program
103 Jones Building/Box 3813
Duke University Medical Center
Durham, North Carolina 27710
Dr. BrocK Neely
InviroSoft
4302 Cruz Drive
Midland, Michigan 48640
Dr. John Neuhold
Department of Fisheries and Wildlife
College of Natural Resources
Utah State University
Logan, Utah 84322
Dr. Verne Ray
Medical Research Laboratory
Pfitzer, Inc.
Groton, Connecticut 06340
Dr* Thomas Waller
Program in Environmental Sciences
University of Texas at Dallas
P.O. Box 688
M.S. BE-22
Richardson, Texas 75080
Support
Ms. Janis C, Kurtz
Executive Secretary
Science Advisory Board
U,S, Environmental Protection Agency
401 M Street, S.W.
Washington, D,C, 20460
Mrs, Lutithia V. Barbee
Secretary to the Executive Secretary
ill
-------
1.0 EXECUTIVE SUMMARY
Public pressure for control of pollutants, and the lack of
resources to support the water quality criteria-setting process
traditionally used for pollutant control have led EPA to propose
the water quality advisory concept for protection of both ambient
aquatic and human health. A water quality advisory (WQA) is a
numeric recommendation that provides an estimate of the pollutant
concentration in water which is unlikely to result in adverse
effects to human health or the environment, even when exposures
are continued for a lifetime. A WQA is similar to a water quality
criteria (WQC) in that each is based on data describing
toxicological effects, however, an advisory is provided when a
lack of data prevents development of a WQC. Application of this
concept clearly has the potential to bring a greater number of
pollutants under regulatory control in a relatively short time.
However, since advisories are based on fewer data, they are
accompanied by increased uncertainty* The Subcommittee arrived
at recommendations and conclusions regarding the advisory
concept in general, In addition, specific findings that address
the guidelines for ambient aquatic life and human health,
respectively, are provided. The recommendations, conclusions and
findings are summarized below.
1.1 The Advisory Concept
The Subcommittee endorses the advisory concept as it applies
to development of ambient aquatic life advisories, provided they
do not substitute for the development of water quality criteria.
The uncertainty attending the advisory concept may cause under or
over protection. Therefore, the advisory process should include
mechanisms for reducing uncertainty as more data become
available.
EPA should consider state standard-setting and management
practices, carefully evaluating the problems that may result if
-------
advisories are adopted as standards. In states where the law
stipulates that water quality standards cannot be made less
stringent once they are adopted, problems may arise as advisories
progress to criteria that are based on more knowledge.
A procedure for selection of chemicals for evaluation should
be incorporated into the advisory process. The Subcommittee
recommends that the chemicals selected for advisory development
be those for which there is evidence of potentially significant
exposure in the environment.
The Subcommittee feels it is imperative that a review
process and public comment period be incorporated into the
advisory process. The increased certainty provided by the peer
review process is necessary to balance the increased uncertainty
inherent in the advisory process.
In general, the Subcommittee had more support for the
concept of advisories applied to protection of ambient aquatic
life than for application to human health protection, primarily
based on the availability of data. A considerable body of
evidence and expertise support procedures assessing risk to
humans. The Subcommittee has reservations about basing
advisories on only a subset of these resources, in contrast,
less data are currently available to support decisions required
to protect aquatic life. Therefore, a program designed to
generate more data to support such assessments and fill in gaps
in the knowledge base can be readily endorsed by the
Subcommittee. Specific findings follow.
1.2 Ambient Aquatic Life Advisories
The Subcommittee endorses the concept of ambient aquatic
life advisories and suggests some modifications to motivate
advances in the area of aquatic effects prediction. First, the
Subcommittee recommends that the Agency provide better guidance
in the supporting documents to ensure that any additional data
-------
collected In response to the advisory process also advances the
understanding of the toxicity of the chemical in question.
In addition, the Agency needs to develop documentation to
demonstrate the basis of each uncertainty factor used in
developing an Advisory. A procedure should be developed to rate
advisories on the basis of the quantity and quality of the data
used to calculate and advisory. The value derived from the
rating system should be presented in the Advisory statement.
The Agency should modify the guidelines to incorporate the
concept of exposure duration and the flexibility to account for
site-specific differences. Another recommended modification is
determination based on effects produced in species that may be
the most sensitive rather than on species that may have
commercial or recreational importance.
The Subcommittee endorses the development of Advisory
guidelines for specific chemical groups based on a justifiable
rationale, such as structural activity relationships. Also, the
Agency is encouraged to develop Water Quality Criteria and/or
Advisories for wildlife protection.
1.3 Human Health Advisories
As previously stated, the Subcommittee has reservations with
applying the advisory approach to human health protection. The
Subcommittee has several recommendations that may improve the
advisory process. For example, secondary sources, those that
summarize the primary journal literature, are recommended for use
only as directories to the primary literature, rather than as
data sources themselves. Secondary synopses often omit pertinent
data in the course of summarization.
The Subcommittee particularly opposes restricting the
supporting literature search for advisories to the most recent 5
years. This restriction discourages the use of the complete body
-------
of information that is available, including older studies at the
foundation of toxicology, and studies that may report important
clinical findings or industrial exposures in humans» In the
opinion of the Subcommittee, a responsible rislc assessment cannot
be conducted without thorough collection, review and
interpretation of all pertinent data.
Guidelines for preparing human health advisories differ from
other risk assessment procedures in the use of modifying factors.
The necessity for "these factors is unclear, and the procedures
for their use are not well developed,* therefore, the Subcommittee
cannot endorse their application to the advisory process. In
addition, the risk assessment procedure described in the
guidelines for human health advisories seems to emphasize
presentation of facts, rather than analyzing and comparing them.
Most of the Subcommittee's criticism is related to the error that
results in assuming that a short risk assessment is easier,
quicker and less expensive than a long one. In fact a properly
prepared, concise advisory could take less paper, but require the
same level of effort required for a criteria document.
-------
2.0 INTRODUCTION
2.1 Origin of the Review
On June 30, 1987, EPA's Office of Water requested that the
Science Advisory Board (SAB) review the draft guidelines
developed for preparing water quality advisories for both human
health and aquatic life protection. SAB reviews are conducted
under the auspices of its Executive Committee. On July 21, 1987,
the SAB received a preliminary briefing on the Water Quality
Advisory Guidelines, given by FranJc Gostomskl, Chief, Water
Quality Criteria Section, Office of Water Regulations and
Standards. The SAB Executive Committee agreed to conduct the
review and delegated responsibility to the Environmental Effects,
Transport and Fate Committee, which established the Water Quality
Advisories Subcommittee to conduct the review and appointed Dr.
Kenneth L. Dickson as the chairman of the subcommittee. The
request for this SAB review is presented in Appendix A.
2.2 Purpose of jbhe Review
The purpose of the review is to provide an independent, peer
assessment of the scientific adequacy of the objectives, rational
and methodology included in the water quality advisory guideline
documents presented to the SAB. The Subcommittee's objectives
are to evaluated the concepts underlying the water quality
advisory approach, and to provide the Agency with recommendations
and suggestions for improvement.
2.3 Review Procedure
The Subcommittee received two guideline documents in advance
of their meeting! 1) Guidelines for the Preparation of Office of
Water Health Advisories, and 2) Guidelines for Deriving Ambient
Aquatic Life Advisory Concentrations. These documents are
included as Appendix B and C, respectively. In addition, the
-------
Subcommittee received some examples of applications of the
guidelines to specific chemicals, including ambient aquatic water
quality advisories for xylene, styrene and tetrachloroethylene;
and human health effects advisories for hexachlorobenzene and
2,4,S-trichlorophenol.
The Subcommittee met in public session on October 22 and 23,
1987 in the Laboratory Conference Room of EPA's Region 3f
Annapolis office at 839 Bestgate Road, Annapolis, Maryland.
David Sabock from EPA, Office of Water Regulations and Standards
described the Agency's need for review and intended application
of the Advisory guidelines. More detailed information was
provided by Frank Gostomski. Specific methodologies and
rationale for development of ambient aquatic advisory
concentrations were presented by Dave Hansen (ERL-Narragansett)
and "Tom Pureell (WQC Section) while health methodologies and case
studies were presented by Cindy Mullen (ECAO, Cincinnati).
Following these briefings, the Subcommittee discussed the
principles underlying the derivation and use of advisory
concentrations in a generic manner. This discussion was followed
by sessions addressing specific aquatic and health issues by
appropriate subgroups of the subcommittee. These discussions
formed the basis for recommendations, suggestions and comments on
the advisory guidelines.
2.4 Description of This Report
The Subcommittee report provides general conclusions with
regard to fundamental concepts, documenting their strengths and
weaknesses. In addition, the report provides a discussion of
specific issues that were identified during the review process,
issues that pertain to both ambient aquatic advisories and health
effects advisories as well as the field of water quality itself
from National and state perspectives.
-------
3.0 THE ADVISORY CONCEPT
Two forces — public pressure for control of the increasing
number of toxicants that cause concern, and laclc of funds to
produce the criteria documents that provide for control of these
toxicants — have pointed to the need for change in the water
quality criteria-setting process, EP&'s solution has been to
develop the advisory concept toether with accompanying guidelines
for setting advisory concentrations.
Ten years ago the Agency signed a consent decree that
obligated production of criteria documents for a list of some
sixty substances. Even with court-granted continuances, criteria
have been developed for only about half of the substances on the
list. Though the remainder are substances of concern, data are
not sufficient to support a full-fledged criteria effort and
substantial laboratory and field testing will be necessary to
obtain a complete data base.
Since there are many toxicants for which inadequate data or
no data exist, application of the advisory concept would bring a
greatly increased number of toxicants under regulation in a
relatively short time. However, these advisories would
necessarily be based on fewer data and, therefore, attended with
greater uncertainty. The consequence of uncertainty is an
increase in the likelihood of over or, in some circumstances,
under protecting human health and/or ambient aquatic life.
Such tradeoffs give rise to concern among members of the
Subcommittee. These concerns translate to reservations with the
concept as expressed in the guidelines. The Subcommittee offers
a series of conclusions and.recommendations regarding the
advisory concept in the.four sections to follow.
-------
3,1 Progressing from Advisories.. £_o_Cr_iter.i.a.
There 'is no trigger within the advisory guidelines for
taking the concentration set by the advisory process to the
higher level of certainty provided by the criteria process, when
the etata do becoiae available* Therefore, there is no motivation
to generate more data,, and no means to reduce "Uncertainty once an
advisory concentration is established. The setting of advisory
concentrations is an appropriate first step in the criteria
setting process, however, it is not an appropriate final step for
either human health or arobient aquatic life protection. The
Subcommittee believes that decision makers will be hampered with
tools that do not reflect the current state of scientific
knowledge and are, in addition, surrounded by uncertainty.
The Subcommittee recommends that a well defined mechanism
for incorporating new data be included in the advisory
guidelines. This mechanism should allow for an provide
incentives for elevation of advisory concentrations to more
certain and well founded criteria concentrations when sufficient
data exist.
3.2 Ant .ld.egr_edat, i on
The WQAs are likely to be used in. a role roughly equivalent
to that of the WQCs in related management programs, states are
likely to develop water quality standards and NPDES (National
Pollution Discharge Elimination Systems) permit programs around
water quality advisories, just as they currently do with water
quality criteria. However, there may be resistance to the
advisory concept in some states.
Since EPA's guidance for developing advisories involves a
conservative approach, they result in a more stringent number.
If a WQC is subsequently developed, it is likely to be both more
certain and less stringent. Some state Attorneys General have
interpreted state laws to mandate that no water quality standard
8
-------
may be made less stringent under the law. Therefore, even if EPA
replaces an advisory concentration with a more certain but leas
stringent water quality criteria concentration, certain states
could be required to maintain overly stringent WQA as the water
quality standard. For this reason, some states are likely to
resist adoption of a water quality standard based on an advisory,
and are likely to wait for EPA to issue subsequent criteria to
prevent establishment of overprotective standards.
3.3 Chemical selection
Risk is a combination of exposure and effect. If there is
no exposure to a chemical then even the most toxic chemical will
pose no risk. Thus it would be a misuse of limited resources to
prepared a advisory document on a chemical for which there was no
established exposure. The extent of exposure may be determined
through the use of on-going monitoring programs, such as those
used by the states in support of the permitting process. For
these reasons, the Subcommittee recommends that chemicals be
selected for the advisory process only if there is evidence of a
significant exposure to the aquatic environment.
3.4 Peer Review and Public Comment
The national guidelines for producing water quality criteria
documents mandate peer review and public comment. The guidelines
for advisories do not. The Subcommittee points out that this
process for producing advisories depends on the opinion of a few,
and believes that this would be a grave mistake. In light of the
more restricted data base that will support advisories and the
increased uncertainty that a restricted data base provides, the
likelihood of producing an inappropriate advisory concentration
is greatly increased, however expert the opinion behind it. The
Agency must outline a process that provides for review by a range
of external authorities in order to capture the best scientific
thinking, broaden the scientific consensus, and minimize future
criticism. Therefore, the Subcommittee recommends that a
-------
procedure for peer review and public comment be incorporated into
the advisory process, and that such a procedure be described in
the guideline documents.
10
-------
4.0 AMBIENT AQUATIC LIFE ADVISORIES; SPECIFIC ISSUES
4.1 Development, Certainty and Quality of the Data Base
4.1.1 Data Base Development
The development of water quality criteria has required an
intensive review of the existing literature, but has also been
characterized by the conduct of extensive laboratory research to
fill perceived data gaps. From the proposed "Guidelines for
Deriving Ambient Aquatic Life Advisory Concentrations" (Appendix
B), it is clear that there will be dramatic differences in the
quantity of data available for establishing an advisory and that
the requirements for additional data will vary for each
substance-specific advisory.
Given the potential for significant improvement in the
quality and quantity of data developed in support of advisories,
it is appropriate for the Agency to provide clear guidance to
ensure the efficient collection of such data. For example, to
comply with current guidelines, a discharger may conduct yet
another generic acute toxicity test to strengthen the data base
for a chemical where three generic tests have been previously
performed, rather than producing data on species of particular
relevance that would be more informative or site specific.
The guidelines recommend that dischargers seele guidance on
development of data from appropriate regulatory agencies. The
Subcommittee recommends that dischargers be guided to develop
data that advance the understanding of the toxicity of the
chemical in question and that advisory documents stipulate the
advances that are needed to strengthen knowledge of the specific
chemicals that they address.
11
-------
4.1.2 Uncertainty
Since the data base contains gaps, there is uncertainty
associated with every advisory estimated. Ideally, the
uncertainty is quantified using a statistical, probabilistic
approach. In the example provided to the Subcommittee, a species
sensitivity factor of 11 and an acute to chronic ration of 25
were documented and used to estimate uncertainty. The
Subcommittee recommends that additional documentation be provided
in guideline documents to clearly define these terms and state
their limits of applicability. In addition, distinctions need to
be provided for application of these factors to fresh and salt
water. Alternatively, generic uncertainty factors could be
tested to provide the necessary refinements in documentation.
4.1.3 Quality Indicators
The Agency has recognized the differences in quality and
quantity of data that are likely to be encountered in preparing
advisories and has developed weighting factors based on the
nature of the available data. Advisory documents will also
contain disclaimers, alerting users that they must consider the
technical basis of the advisory before application and that
advisory values are derived less stringently than criteria. The
Subcommittee believes that a quality designation should also be
associated with the advisory concentration to indicate the
certainty or confidence attached to the advisory number, and the
fact that confidence varies. Such quality designations could
take the form of descriptive statements or numerical indicators.
4.2 Considerations__for Modifying the Advisory Process
4.2.1 Exposure Duration
As currently advanced a water quality advisory will consist
of a single concentration below which aquatic life are assumed to
be protected and above which adverse effects may occur. The
12
-------
advisory concentration is designed to protect those exposed from
chronic effects and is analogous to the Criterion Continuous
Concentration (CCC) of a water quality criterion. However, an
advisory does not contain the concept of exposure duration which
is an integral part of the CCC of a water quality criterion. If
advisories are used as surrogates for criteria as stated in the
briefing to the Subcommittee, then the Agency should consider
modifying the advisory to include the concept of exposure
duration. The CCC of a water quality criterion states that
ambient levels cannot exceed the CCC for more than four (4) days.
The inclusion of duration of exposure recognizes that effects are
a function of both concentration and time of exposure. This well
established toxicological principal should be reflected in the
water quality advisories particularly if they are used for
regulatory purposes.
4.2.2 Species Beyond Commercially or Recreationally Important
Ones
The Subcommittee believes that a reduction in advisory
concentrations is warranted if laboratory or field data for any
species, regardless of whether or not it is considered
commercially or recreationally iaportant, indicate that it is
affected at concentrations below the calculated advisory
concentration. Both the national water quality criteria and the
aquatic life advisory concentrations must be reduced if
"commercially or recreationally important species" are found to
be affected at lower levels than predicted by the final acute or
chronic values. Restricting this adjustment to only important
species is inappropriate for the advisory concentrations.
Because advisory concentrations may be based on only three
species, the potential for missing important species is increased
greatly,
13
-------
4.2.3 Site-Specific Modifications
The guidelines for deriving water quality advisories are
designed to produce a conservative value, thus/ advisories may be
over protective at many sites. A procedure for site-specific
modifications, which could require generation of additional acute
and/or chronic data for species appropriate to the site, would not
only increase the data base for the chemical but would account
for water quality interactions which may affect the
bioavailability of the chemical. A site specific modification
approach would be especially applicable to metals, organic
compounds that ionize, and those that have high partition
coefficients, and could also be adapted from the existing
procedure for site-specific modification of water quality
criteria.
4.3 Considerations for Developing. Other Advisories
4,3.1 Guidelines for Specific Chemical Groups versus Generic
Guidelines
The Subcommittee endorses the development of guidelines for
specific chemical groups, such as the guidelines reviewed by the
Subcommittee for low molecular weight, non-ionizable organics.
The Subcommittee agrees with EPA that, because of varying fate
and effects among groups of chemicals, initial development of
generic guidelines is inappropriate. Guidelines for specific
groups of chemicals should clearly indicate the chemical group
addressed in the document title, as well as in supporting text.
The Subcommittee suspects that differences in guidelines
between most different groups of chemicals will be small. The
acute to chronic ratio (ACR) of 25 used in the guidelines may
serve for a broad range of chemicals, since a variety of
chemicals were used to derive it. Similarly, the factors used to
calculate the advisory acute value (AAV) are related to the
number of Genus Mean Acute Values (GMAV) available, and should
14
-------
not be significantly different among chemical groups. The use of
these parameters generically for chemical groups may be
substantiated by clarifying and justifying their derivation in
supporting documentation.
The major differences between guidelines for different
chemicals will likely be in numbers and kinds of species to be
tested. The AAV for ionizable molecules, metals and perhaps
other groups of chemicals may need to be based on a larger number
of representative species from both fresh and salt water. Also,
water quality characteristics such as hardness and pH may need to
be considered. If there is potential for a greater effect on
aquatic plants than animals, as with herbicidal chemicals, then
at least one acute test with plants must be required.
4.3.2 Development of Advisories for Wildlife
The Subcommittee points out the fact that waterfowl, birds,
mammals, reptiles, and amphibians are valued environmental
resources and that they are exposed to chemicals via food, water
and other routes. Water quality criteria incorporating
bioaccumulation, whether based on risk assessment assumptions or
FDA action levels for human consumption of fish, may not be
adequate for wildlife protection. The reasons include important
differences in metabolism, feeding requirements and body weight.
For these reasons, the Subcommittee recommends that the EPA
consider the development of water quality advisories for
wildlife.
15
-------
5.0 HEALTH EFFECTS: SPECIFIC ISSUES
5.1 Data Base Development
The basic methodology for risk assessment outlined in the
"Guidelines for the Preparation of Office of Water Health
Advisories" (Appendix C) do not differ markedly from those
currently used by the Agency for setting drinking water health
advisories. Current methods for developing health advisories to
protect human health are based largely upon an intensive
collection and review of the existing literature. Research needs
may be identified, but, unlike establishment of criteria for
protecting aquatic life, additional laboratory research is almost
never conducted.
5.1.1 Secondary Sources
The guidelines call for the use of secondary sources, which
summarize, annotate and compile primary or journal literature, in
preparing health advisories. While the Agency should use the
existing literature efficiently, misconceptions and confusion can
arise for the use of secondary sources. Misconceptions can be
introduced due to the fact that the studies likely to be
summarised in secondary sources were originally designed for
purposed other than safety evaluation. Confusion arises because
the details necessary for appropriate integration, understanding
and analysis of the data are often omitted in such summaries.
Although they may serve as efficient directories to primary
literature, the exclusive use of secondary sources can not be
supported by the Subcommittee.
5.1.2 Literature Searches
The Subcommittee considers the restriction of the literature
search to the most recent 5 years, as prescribed in the guide-
lines, to be a major problem. Such a restriction discourages and
may prevent the use of many older studies that report significant
16
-------
exposures and effects in humans, especially as a result of
industrial exposures. These studies are often supported by
experimental studies in animals which provide basic information
on acceptable levels of industrial exposure in humans, While
concise presentations may be appropriate, responsible development
of a risk assessment requires thorough collection, review and
critical interpretation of all pertinent data.
5.2 Modify, ing Factors
The proposed use of "modifying factors" appears to the
Subcommittee as a major methodological feature that
differentiates the advisory-setting procedure from other risk
assessment procedures previously reviewed by the Science Advisory
Board, As presented in the guidelines, the purpose and necessity
for this feature is unclear. The presently used methodology for
establishing water quality criteria encourages the use of
scientific judgment in the selection of the most appropriate data
for assessing risk and uses four uncertainty factors which can
vary depending on the quality of the data. Data on
pharmacokinetics and bioavailability are also used quantitatively
to adjust data in risk assessments. However, the proposed
modifying factor appears to be little more than a "fudge factor"
which has a high potential for abuse in "adjusting" the outcome
to preconceived values, rather than values that are consistent
with scientific and toxicologic data. In the opinion of the
Subcommittee, the proposal to use modifying factors is not well
developed, is not necessary, and can therefore not be endorsed.
5,3 Data Analyses
Since the proposed guideline documents are similar in purpose
and methodology to water quality criteria documents, it is
reasonable that the outline and topics included therein are also
similar. However, the tone and tenor of the guidelines reflects
a substantial degradation of the risk assessment process. The
document discourages the critical analysis and synthesis of data
17
-------
where it should be encouraged. The guidelines call for an
encyclopedic presentation of facts in a rigid format, followed by
a risk assessment protocol which emphasizes arithmetic rather
than analysis.
The Subcommittee encourages guideline revisions that promote
standardization within sections to encourage comparison between
studies. In addition, it recommends that discussions be included
to relate the elements of the outline to the derivation of
advisory concentrations.
5.4 Conclusion
Most of the criticism raised by the Subcommittee can be
related to a fundamental flaw in the basic assumptions underlying
the development and use of water quality advisories to protect
health. Namely, this assumption is that a good, short risk
assessment is substantially easier, quicker, and less expensive
to prepare than are long reviews and risk assessments. While a
properly prepared and appropriately concise health advisory could
save paper, it will reguire the same level of analysis and effort
needed for a criteria document. In many respects, the imposition
of an economy of words requires more effort in preparation than
longer detailed reviews. In fact, the advisory process used for
health effects assessments may compromise the Agency's efforts to
provide sound guidance on tolerable levels of compounds in
ambient water.
18
-------
APPENDIX
Request for the Review
-------
UNITED STATES ENVIRONMENTAL PROTECTION AGENCY
WASHINGTON, D.C, 20460
30 BW „„,„„
WATER
MEMORANDUM
SUBJECT; Request for SAB Review of Water Quality Advisory
Guidelines
FROM: Edmund M. Notzon, Director fcf.*^***^-*/ /Wfj^T^
Criteria and Standards Division (WH-S85)
TO: Terry Yosie, Director
Science Advisory Board (&-1Q1)
I an requesting the Science Advisory Board review draft
guidelines developed for preparation of water quality advisories
for both human health and aquatic life protection. The draft
guidelines are attached as are copies of completed advisories
which were developed using the draft guidelines.
Water quality advisories are intended to be used as a
supplement to our efforts to develop water quality criteria
recommendations under Section 304(a), of the Clean Water Act.
Advisories are designed to fill the gap between the large number
of pollutants and the limited number of criteria documents we
are able to produce. Advisories basically provide the Agency's
best scientific judgment applied to existing information,
Please let me know as soon as possible when the Science
Advisory Board will be able to conduct a review of the advisory
guidelines. Dr. Frank Gostomafci (475-7321) may be contacted
for further information.
Attachment*
-------
APPENDIX B
Guidelines ....for Deriving Ambient Aquatic Life
Concentrations
-------
:i/£v'
GUIDELINES FOR DERIVING AMBIENT AQUATIC LIFE
ADVISORY CONCENTRATIONS
~mfl.fi
- r
Office of Water Regulations and Standards
Criteria and Standards Division
Waihington, D.C.
Office of Research and Development
Environmental Research Lab
Duluth, MN
Environmental Research Lab
Narraganaett, RI
June 1987
-------
I. introUuct
Aquatic life advisories will oe issued for selected
chemicals £or which not enough toxicity, bioaccustulation
and/or field data are available to allow derivation of
ambient *ater quality criteria for aquatic life using
the procedures describe'! in "Guidelines for Deriving
•jj'im-arical National Water Quality Criteria £or the . .
Pro--Action of Aquatic Organises and Their Uses" (Stephen
et 41. 1935), hereinafter referrred to as the "National
Guidelines". Aquatic Life advisories will contain
compilations and interpretations of available data
than, \cs lirectiy pertinent to the derivation of
aquatic life advisory concentrations.
Aquatic life advisory concentrations are intended to
be used mostly for evaluating the aquatic toxicity of
concentrations of pollutants in effluents and ambient
waters, whereas water quality criteria for aquatic
life provide a stronger basis for regulating concentra-
tions of pollutants in effluents and ambient waters.
A-lvisory concentrations have the following two intended
uses:
1. Advisory concentrations are intended to be used to
interpret data on concentrations of chemicals in
ambient water. If the concentration of a chemical*
in ambient water is equal to or below .the aquatic
life advisory concentration for that chemical,
there is probably no cause for concern about
effects on aquatic organisms and their uses. If,
however, the ambient concentration is above the
advisory concentration, the discharger should
quicKly evaluate the available exposure and effect
data to determine whether it is prudent to:
a, obtain additional data concerning the concen-
tration of the chemical in the effluent and/or
ambient water;
b. obtain additional laboratory and/or field data
on the effect of the chemical on aquatic
organisms and their uses so that a more accurate,
and usually higher, aquatic life advisory or a
water -quality criterion can be derived;
c. conduct acute and/or chronic toxicity testa on
the effluent; and
d, reduce the ambient concentration of the chemical
-2-
-------
After a reasonable period of time, the
• regulatory agency should evaluate all available
pertiiant data, concerning the aabient concentration
and the effects of the pollutant on aquatic life
to determine whether it is appropriate to take an/
action such as establishing a permit limit Cor the
pollutant or requiring toxicity tests on the
effluent. Such agency aiay choose to regulate
. either before or after collecting additional data,
2, Advisor/ concentrations are intended to be used to
help the U.S. SPA select chemicals for which water
quality criteria for aquatic life should be derived.
Any chemical that is found to be present in a
considerable number of ambient waters at concentrations
simil-ar to or exceeding the advisory concentration
may become a candidate Cor derivation of water
quality criteria for aquatic life. Thus advisories
will provide dischargers with advance notice of
chemicals for which criteria might be derived so
that they can generate additional data that might
be useful for revising the advisory concentration
or for deriving water quality criteria for aquatic
life.
Additional guidance on appropriate regulator/ uses
of advisory concentrations and criteria should be
obtained from the Criteria, and Standards Division,
Office of Water Regulations and Standards/ U.S. EPA,
The procedures described in the National Guidelines
will be used as much as possible in the derivation of
aquatic life advisory concentrations. Whenever a
procedure described in the National Guidelines cannot
"oe used (usually because some required data are not
available), a procedure that (a) follows as closely as
possible the procedures described in the National
Guidelines and (b) is compatible with the intended
uses of advisory concentrations will be developed for
use in deriving advisory concentrations. Aquatic life
advisory concentrations caa be based on fewer data
than can water quality criteria for aquatic life
because advisory concentrations are not intended to
have as much regulatory impact as criteria. However,
to be compatible with the first intended use, advisory
concentrations must be derived so as to ensure that
-3-
-------
they are rarely, if ever, higher than what the Criterion
Continuous Concentration (CCC) -would be if enough data
were dvailable to allow derivation of a. national aquatic
criterion £or the chemical. The data requirements and
procedures use-1 £oc -iecwing aquatic life advisory
concentration is rarely, if ever, above what the CCC
wouL'1 bs. Thus, whenever i national criterion is
derived for a pollutant foe which an advisory
concentration is already available-, the CCC will almost
always be higher than the advisory concentration. On
the other haaJ. an advisory concentration that is too
much lower than the CCC will cause unnecessary concern
about various chemicals, effluents and ambient waters,
To be most useful, the advisory concentration should
never be above what the CCC would be and should rarely
be more than a factor of 10 less than the CCC.
D, in order to obtain acceptable advisory concentrations
for the least cost, the data requirements and procedures
jsed for deriving aquatic life advisory concentrations
will be different for different classes of chemicals.
when possible, classes will be defined so that data
requirements and procedures can be appropriately based
on the biological, chemical, physical and toxicological
properties used to define the class.
II. Low Molecular Weight Jlon-idnizable Organic Chemicals
A. This class of chemicals is not very well defined yet.
It is expected, however, that all low molecular weight
non-ionizable organic chemicals will be in this class
after an upper limit on molecular weight has been
established. It might be possible to expand this
class to include a wider range of chemicals within
certain limits.
I. 'This class ia intended to be limited to chemicals
for which ther« is no reason to suspect that the
range of acute or chronic sensitivities of saltwater
species will differ substantially fro» those of
freshwater species. Therefore, unless thare is
substantial evidence to the contrary, the data
available for freshwater and saltwater species
should be considered together in order to derive
an advisory concentration that will apply to both
fresh and salt water* Because of the differing
ionic compositions of the waters, it seems reasonable
to assume that the toxieities and BCFs of organic
-4-
-------
chemicals that ionize and inorganic chemicals are
Likely co (iiESec in Sresh and salt water.
2, This class I* Also intended to be liinitsd to
chemicals whose range o£ toxiciti^a to aquatic
animal spscles id relatively snail, so that the
requirement's Sor acute values do not have to
include very many species and do not have to be
very specific. Thus this class o£ chemicals should
.lot include any pesticides that are intended to be
effective against any aquatic or terrestrial
animals or any metals.
3- This cla^g is also intended to be Limited to
chemicals that are not especially toxic to plants,
so that tests with aquatic plants do not have to
be requital. Thus this class of chemicals should
not include any herbicides.
B. An aquatic life advisory concentration should not be
calculated for a. chemical unless data ace available
from acceptable acute tests *ith at least three aninal
species, such that:
1. at least one species is a fish In the class
Osteichthyes in the phylum Chordata.
2. at least t*o species are invertebrates such that;
a. at least one species is in the class Crustacea
in the phylum Arthropoda.
Q. the'other species is either in the phylua
Mollusca (test with embryos "and larvae leading
to a 96 hour £CSO or LC50) or in a different
family of the jphyluw Arthropoda.
3, at least one ia a freshwater species.
4. at least ona is a saltwater species.
Available data from foreign species should bs
included in the advisory* but not utilized to derive
an advisory recommendation unless other required
data is not sufficient.
— 5 —
-------
Because .!iaiy o£ the chemicals in this class -ira highly
volatile or .legradable, -acute tests with animals and
tests with plants that *r-3 otherwise acceptable (in
terms of acclimation, control mortality, ate. as
described in the National Gvii del in.es) are acceptable
•for this class 06 chemicals only if:
|j£. For flow-through t^sts, the concentrations wars
','.". measured. If concentrations fluctuated unreasonably,
•the test should not ba
2. Foe renewal tests t th« organisms were exposed to
fresh test solution a.t least once evety 24 hours
an»1 either (a) the properties of the chemical
indicate that its concentration in water should
not decrease by more than 501 in 24 hoars or (b)
measurements on tests solutions showed that the
concentration of test material did not decrease by
aote than 50% in 24 hours.
+
3. For static tests, either (a) the properties of th«
chemical indicate that its concentration in water
should not decrease by more than 50% in .96 hours*
("o) measurements on teat solutions showed that 'th«
concentration o£ test material did not decrease by
more than 50% Iron the beginning to the end of the
test or (c) results of a nominal or measured static,
test should be multiplied by a factor obtained by
dividing a f low-through 96-hr LC50 by a- comparable
static 96-hr LCSO. The comparable flow- through
and static tests must b* conducted on the chemical
in the same laboratory using the same water and
organisms from the same sources. The results of
the flow-through tests must be based on the time-
weighted average measured concentrations of test
material and the results of the static test must
be baaed on th* concentrations measured at the
beginning of the test.
D. Although data from tests with aquatic plants ar«
desirable th«y are not required because for many chemicals
it appears that aquatic plants are adequately protected
if aquatic animals are adequately protected.
£. For each species for which at least one acceptable
acute value is available, determine a Species Mean
Acute Value (SMAV) using the procedure described in
-6-
-------
the National Guidelines- (if data from tests in both
fresh and salt water are available for a species such
as .-striped bass, all the data should be used together
-*hen determining the SMAV for that species.) Than
calculate a Genus Me-in teute Value (GMAV) £pr each
' genus for which at Isast one SMAV is available.
F.;;||itB F-W should be calculated using the procedure
'"'described in the National Guidelines if GMAVs are - -
aviilAOle Cor at least one animal species in at least
eignt different families, such that either?
1. the acute data requirements specified in the
National Guidelines for either fresh or salt water
are met, or
2. all the following ar« includeds
a, three families in the phylum Chor«Sata such
that:
(1) at least one species is in the family
Salmonidae.
(2) at least on* is a freshwater species.
(3) at least one is a saltwater species.
b. i saltwater penaeid shrimp or mysid.
c. a freshwater cladoceran.
3, a family in a phylum other than Cliordata or
Arthropoda.
e. two other families not in the phylum Chordata.
As described in the national Guidelines, in some
situations a calculated FAV should be lowered to protect
an important animal species.
G. If th« requirements far calculating an FAV are not met,-
calculate an Advisory Acute Value (AAV) by dividing
the lowest available GMAV by the appropriate factor:
Number of GMAVs Factor
3 11.0
4 10.0
-7-
-------
Number, of GMAVs
5
6
3
9 '
10
11
12
13
14
15
16
17
18
19
20 or more
The AAV is intended to be equal to or slightly below
what th* FAV would be if one could be calculated.
Since the factors for 8" GMAVs and above are only to be
used when those GWAVs are not acceptable under the
National Guidelines, the lowest factor has been set at
2, to provide a conservative estimate for the advisory
concentration, if there are 3 acceptable GMAVs, then
an PAV can be calculated directly.
H. II three or more experimentally-determined acute-
chronic ratios (ACE) which are acceptable based on the
-8-
-------
National Guidelines ara available for the chemical,
determine the Final Acute-Chronic Ratio (FACR) using
the procedure described in the* National Guidelines,
If £e*qr than three acceptable axp*cimentally-deterained
ACRs are available, use enough assumed *CRs of 2S so
the total n amber of exparimeatally-tleter mined and
ACRs equals three (over 90% of the ACR reported
both Kenaga (1932) and Call et al. (1985) were'less
2^5 and nearly ail the F&CRs used to derive watir
quality criteria for aquatic life have been less than
25), Calculat-a the Advisory Acute-chronic Ratio (AACR)
as the geometric mean of the three-*ACRs, Thus is no
experimentally-determined acute-chronic ratios are
available/ the AACR is 25.
I. Calculate the advisory concentration by dividing the
FAV (or the AAV if an FAV cannot be determined by the
- FACR (or the AACR i£ an FACR cannot be determined).
J. If necessary, the advisory concentration should be
lowered to one-half of the lowest EC50 for an important
aquatic plant species for which the ECSO is available
from' *n acceptable test, based on the National
Guidelines, in which the concentrations of teat
material were measured and the effect was biologically
important.
i *
K. If a Maximum Permissible Tissue Concentration (either
an FDA or othar regulatory action level far seafoods
or from wildlife feeding studies, as described in the
National Guidelines) is available, bacfc-calculate to a
concentration in water using a measured BCF (or a
predicted BCF if a measured BCF is not available). If
necessary, the advisory concentration should be lowered
to be equal to the calculated concentration.
L. The advisory should be stated ass
If the measured or estimated ambient concentration
of (a) exceeds (b) in fresh or salt water, one or
mor* of th« following options must be completed
as quickly as possible;
1. obtain additional data concerning the concen-
tration of (a) in the effluent and/or ambient
water;
2. obtain additional laboratory and/or field data
on the effect of (a) on aquatic organisms and
their uses so that a new aquatic life advisory
or a water quality criterion can be derived;
-9-
-------
3. conduct acate and/or chronic toxicity tests
on the affluent?
4. rsduce the concentration.
After a reasonable period of time, unless a
of all avail-able data concerning the ambient concen-
and the effects of (a) on aquatic life demonstrate
.t'aat the ambient concentration is low enough, it fnust be- -
reduced,
'.vhace (&}j~ insert name of chemicai and
(b) = insert advisory concentration
M. Caveats should be added to the advisory statenent in some
^situations;
1, if data for a commercially or recraattonally
important species indicate that the species might
not be adequately protected by the advisory
concentration, but the data do not justify lowering
the advisory concentration (for exanple, because
the concentration of test material wer* not
maasucsl), caveat should be added stating that tfc*
species might not be adequately protected.
2, If SCSOs for a variety of species of algae (or
aquatic plants in general) are below the advisory
concerttration, a caveat should be added stating
that algae (or aquatic plants) might not be
adequately protected. •
-10-
-------
References
Call, D..JT.. * L.T. Brooke, M,L. Knuth, S»H. Poiciac and M.D.
1,995. Fish subchroaic toxic it/ prediction
for industrial organic: chemicals that produce
id, Snviron. ToxicoL. Chem. 4t335-341.
Kenaga, E.£. 1932. Predlcatability o£ chroaic toxicity from
acate toxicity of cheiticals in fish and invertebrates.
Environ. Toxicol. Chen. li347-358.
Stephen, C.E./ D»I. Mount, O.J. Hansen* J.H. <3entilef Q.A.
Chapman and W,A. irunga, 1985, Gaidellnes Cor deriving
numerical national water quality criteria for the protection
of. aquatic organisms and their uses. PB85~227049» National
Technical Inforaation Service, Springfield* Va*
-11-
-------
f* ' APPENDIX C
,:-"^:,~ •;
Guidelines for til® Preparation fif Office of Mater
t
Health Advisories
-------
APPENDIX C
Guide_lines_for the Preparation of Office Qf_wa£.eg
Health Advisories
-------
GUIDELINES FOR THE PREPARATION OF OFFICE OF MATER
HEALTH ADVISORIES
U.S. Environmental Protection Agency
Envlronmtntal Criteria and Assessment Office
Cincinnati, OH 41268
May 6, 1987
-------
INTRODUCTION
These guideline! were prepared to assist authors and others involved \n the
preparation of Health Advisory |HA) documents for the U.S. Environmental
Protection Agency (EPA), Office of Orinklnf Mater (QDW) and the Office of
Water Regulations and Standards (OURS),
The HA document provides a quick review and summarization of the key
11 teraturf^en the physical, chemical and toxUologlcal properties of the
specif led^itflilcal. Kty literature contains Information hawing a direct
effect on .in* estimation of an MA or provides Basic scientific Information on
the chemical 0f interest. When available, existing documents and reports will
be heavily relied upon to complete this document. The HA d§cument is used by
£PA to aid In determining control priorities when tht chemical 1s present In
ambient or drinking water. The calculated and extrapolated HA values included
within the HA document are not legally enforceable ambient or drinking water
standards.
LITERATURE SEARCH
To provide literature search and acquisition support consistent with the
magnitude of the entire effort, the literature search for a HA document will
rely heavily upon those searches already performed In support of available,
good quality primary references or summary documents on the chemical. As a
minimum, a limited (last five years or 2-3 years prior to most recent
reference dted in an existing document) automated literature search will be
performed to ensurt Identification of tht mort .recent technical IHeraturt,
Typically, the available summary documents and IHtraturt starch outputs wrtli
then bt forwarded to tht author for his selection of tht key primary
literature rtferences to bt acquired during preparation of tht HA. On
occasion, an Initial selection of the key literature will bt performed by EPA
staff prior to the author's Involvement. The contractor's support staff win
acquire coplts of the selected reftrtnces and thtst will be forwarded to the
author to permit Initiation of the original writing tasks.
Primary References ' -
Due to the magnitude of tht effort, existing documents and reports must be
heavily relied upon. To avoid transferring Interpretations! or typographical
errors to the HA from secondary references spot checks will bt done.
Secondary references (e.g., chemistry texts) may be used tn the preparation df
Section II (Gtntral Information and Properties). Secondary rtftrtnces will be
cited when tnty art tht original sourct of Information. For example, an
existing IPA document My bt a secondary reference for toxicology data but the
primary soyrct for txtrapolations from that data to hymans (i.e., primary
reference for existing guidelines or standards).
Kev Reftrtnct
Only a limited number (average of 20) of literature rtftrenets art usually
specifically dted In the HA document. Tht selection of reftrencts to be
-2-
-------
- '- - - '• .. H« «••'. i.',/ -•"•* M.WJL *.•'','vj* ilcjj '. i"i t i IB pf epdf <311 on process. The HA
documents are not comprehensive reviews of all of the literature on each
ambient or drinking water contaminant, Conciseness Is maintained by selecting
only the most Important/valid references for citation. Emphasis must be on
the determination of the NOAEl and/or the LQAEL. This establishes the overall
scope and technical emphasis of the HA.
The selection of key references Is also Influenced by the technical "emphasis"
°" oral exposure. Preferably, studies selected for Inclyslon into 'the HA win
Involve ('If'oral exposure-food, drinking water, gavage. (2) .dermal
exposure/ibsorpnon and (3) Inhalation exposure If pertinent Information on
the chemlcaVls provided or if there ar* no other data available. Studies
involving other typts of exposure are only useful when more pertinent data are
licking.
* y
Pesticides/Confidential Business Information
For HA documents on pesticides, etc., a special consideration is often
encountered. Much of the toxicology and pharmacology data may hive been
developed by industry and, for proprietary business reasons, classified as
Confidential Business Information (Cil). This CBI Information cannot be
released to the public unless specific authorization U provided by the
submitting Industry. When such a situation 1s encountered, tilt document will
use the CBI information 1n calculating the advisory, and non-CBl summaries
will be included. Sanitized copies of any literature that Is of importance
should be on file. The author will be authorized to access the CBI and
Instructed to Incorporate non-CBI summaries Into the HA from the CSI sources.
Here a disclaimer Is employed to explain why certain details (CBI) are not
included. Special Instructions are provided to the author regarding the*
preparation of non-CII summaries for Inclusion In the HA document.
Reference Hard Copies
Two copies of every cited reference will be obtained and submitted to EPA.
The author may dte references from his/her personal reference collection or
other readily accessible sources. It 1s emphasized that two legible copies of
each reference must be provided with the HA document,"draft.
Translations
Due to the significant costs that can be Incurred, translations of foreign
language references art generally avoided and, if absolutely needed, are dealt
with on i case-by-case basis. The author must identify all desired
translation requirements early In the HA preparation process and check with
the IPA HA manager to see If IPA already possesses a translation or If IPA
chooses to translate the reference Itself.
DOCUMENT ORGANIZATION
The organization of an HA document Is designed to achieve a uniform and
effective summary of the pertinent data needed to determine a HA. An outline
,3,
-------
of the major sections 1s given later Including suggested contents of each
sections, More information 1s. described here concerning the technical
emphasis, presentation format, and document tone desired for the document.
This rigid structure frequently poses organizational problems with respect to
presenting the results of experimental studies, since data pertinent to two or
more sections of the outline are often presented 1n a single research paper.
Experience;-Jias shown that the best way to solve this problem is to "summarize"
the resylffeof each study, presenting the results of Individual experlnents
{or groypf^f similar experiments) under the appropriate outline headings.
This plan dors lead to some redundance with regard to the description of
experimental conditions (see below), byt nevertheless it Is the format that is
most useful to tht various users of the HA documents.
.*
TECHNICAL EMPHASIS
The HA document must be a technical docyraent. EPA science policy, economic or
political considerations are not an issue during the selection of references
or the preparation of the document. The technical emphasis in the HA document
Is with the presence of the specified chemical In water. Thus, all chemistry
related portions of the document (physical, chemical properties, chemical
analysis) should emphasize the chemical's properties and behavior in water and
accumulation In aquatic life. The health effects portions of the document
should emphasize the compound's lexicological properties by the most relevant
route of exposure, (I.e., oral and derrwal exposure). Toxicology Information
for other routes of exposure may be Included as background material for
toxlcologlcal discussion. However, due to the .limited scope of these
documents and magnitude of the effort, such discussion will tie minimal should
H occur at all.
FORMAT FOR PRESENTING EXPERIMENTAL RESULTS
Each experiment (or group of related experiments) should be described 1n a
paragraph that is an independent unit, able to stand alone. This format H
needed to provide a concise summary of the key information and for locating
Hems of Interest relative to a specific exposure situation. The format is
also useful during HA revisions yhen additions, deletions or rearrangements
may be made.
The text describing the results of Important experimental studies must provide
sufficient experimental detail to allow the reader to form an independent
opinion regarding tn« quality and importance of the results. (Such opinions
may. be offered by the author of the HA but must be clearly Identified as
such). If available, the following Information must be Included (more or less
in order) \R the paragraph describing an experiment or series of related
experiments.
1, The literature citation (in proper format) is contained in a brief
Introductory sentence. The format for citing references *t1ll be
provided and examples are given later.
-4-
-------
2, Species of test animals {ana strain, sex, age. body weight \f
critical to tne results interpretation),
3. Chemical form (e,g,, "copper as
-------
, calculate the average daily aose (mg/kg/day} over the duration of the
study. In calculating tht dost in mi/kg/day, carry only as many significant
figures as are reported by the authors. Often, all Information required For
calculating the dose in «g/kg units 1s not available in the cited reference.
and assumptions must tie made. AH such assumptions must be clearly laoeled'as
such. In order to keep track of all experimental details and tnt dose
calculations. It Is suggested that a worksheet be filled out for each
llterature.;Ftport used, providing tht basis for all details and mathematical
conversion"^-made. These worksheets, as well as other supportive materials,
should become part of tht document file and a copy provided to EPA,
TON!
/ .•
All sections of the HA document must be concise, accurate, factual, objective
and neutral summaries of the Important work: that has been reported in the
literature. The author of the' HA document is not permitted to make deductions
or extrapolations from the data into the ftport, regardless of the logic and
accuracy of the extrapolation. Deductions and extrapolations made by the
author of the citation may be reported, but must be clearly indicated as
such. It 1$ emphaslied that the HA author's technical expertise and Judgement
is required to make critical decisions during the selection of those key
references to be reviewed and cited 1n the HA. 8ut, with tht exception of the
section on "Quantification of ToxUologlCIl Effects* the HA document 1s to be
only a summary (not an extensive critical review) of tht key Information.
Example text
The following paragraphs are offered as examples of the organization, content
and style that 1s desired In descriptions of experimental results.
Single doses of compound X at 1.0, 2.5, 5 and 10 mg/kg administered by
intravenous injection in (vehicle) to rats (age, sex* strain), 10 animals
per dose, were shown "to cause (effect) it doses >2.§ mg/kg. A dose of 1.0
mg/kg caused no (effect) (Hllltr et al., 1S83).
Adult Sprague-Dawley male rats were administered compound X In their
drinking water at dosts of 0, 200 or 2,000 ppm (0, 10 or 100 mg/kg/day)
for U consecutive days (Smith, 1977b). The number of animals used was
not reported, A NOAEL of 200 ppffl dost (10 fltg/kg/day} was Identified
showing no effect(s) on . The 2,000 ppm dose (100 mg/kg/day) caused
(effect). In a liter review of tht study, U.S. EPA (19SO) Identified
several problems with tht study, which may have compromised tht results.
The format specifications should be approached as the maximum requirement for
each summary. Typically, sont abbreviation is acceptable to make the HA
concise and describe those aspects of each study that contribute the important
information, Tht author, however, should be conservative in preparing
abbreviated summaries. The IPA reviewers have final authority over HA
document content. The deletion of "unnecessary" experimental details Is
easier than later revaluation of the primary reference to tipand tht text.
-6-
-------
The section on "Quantification of To*1cologtcal Effects", However, does
tnat the author mike scientific Judgments and thus, departs from the
objective, neutral and factual summary tone of all other HA document
sections. In this section, the author must select specific sets of data to &e
used for each _-WA calculation. This data is then used with EPA established
guidelines to estimate acceptable levels.
HEALTH AO^ISORY CALCULATIONS
, -*>
. %•%-
Calculation's "of, HA values are required for 1-day and 10-day periods as well as
longer-term and lifetime HA values 1f adequate subchronlc and chronic toxlcity
data are available. For all such calculations, extrapolation of animal
toxlelty data to human* will probably be required. The 1-day, 10-day and
longer-term for a child HA calculation shall be based on a 10-kg child who
consumes one IHer of water per day. Tht adult longer-term and lifetime
health calculations shall oe based on a 70-kg adult who consumes two liters of
water per day. lach HA calculation requires the selection of the best single
data-set. These data must be (1) of high quality, (2) from a study where
evaluations of target organ effects have been observed. (3) from a study using
the most relevant route of exposure and (4) for a study duration comparable to
that for the HA value being calculated. A 1-day HA can use up. to a 7-day
study; a 10-day HA can use up to a 30-day study; a longer-terra HA can use a 30
to <90-day study or 10% of the animals' lifetime; a lifetime HA can use >90
day study. Appropriate uncertainty factors are then applied to derive the
calculated HA exposure levels discussed below.
Quality
The quality of available data-sets will be a Judgment resting primarily with*
the HA author. Publication of tox1c1ty data In reputable "peer -reviewed*
toxicology or medical Journals should be used is one measure of data quality.
Informal coordination with the study authors or other experts active in this
technical field may also-be required to assist In assessing the quality of
data being considered as the basis for an HA calculation. Discussion with the
EPA staff is encouraged during the course of the assignment to review the
quality aspects of data being considered.
Target Organ iffects Data
The selected data-sets must be from studies where observations for "target
organ effects" (e.g., observations for effects other than or in addition to
lethality) have been made. The following priorities should be applied in the
selection of studies for use in calculating HA values (1) dose-response
studies in wMcn a NOAEL 1s Identified, (2} studies employing a single dose or
multiple dost that did not produce an effect (a mini mum NOAEL) and (3)
dose-respoflse studies In which the lowest dose tested still produced an effect
(LOAEL only). In cases where there ire two or more sets of reliable animal
toxlcHy data* the data set that represents the highest NOAH or the lowest
LOAEL will be used,
-7-
-------
Lethality data (regardless of quality) should not be used as the basis for
-------
Uncertainty rac.to.rs
A NGAEt or LOAEL 1s determined from animal toxldty data or human effects
data, for animal data, this level 1s modified by an uncertainty factor mainly
because tnerejls no universally acceptable quantitative method to extrapolate
from animals 'to humans, Tne possibility must be considered that hymens are
more sensitive to the toxic effects of chemicals than are animals. For human
data, anjncertalnty factor 1s also used to account for the heterogeneity of
thf huma^populatlbn In which persons could exhibit differing sensitivity to
toxic chepfGals. The suggested modification of the guidelines set forth oy
the National'Academy of Sciences and modified by the U.S. EPA I986a typically .
used 1n establishing uncertainty factors are as follows;
Standard Uncertainty/Factors (Ufs)
« Use a 10-fold factor when extrapolating from valid experimental
results from studies using prolonged exposure to average healthy
humans. This factor is Intended to account for the variation in
sensitivity among the members of the human population, [1QHJ
Use an additional 10-fold factor when extrapolating from valid
results of long-term stymies on experimental animal* when results of
studies of human exposure are not available or are 'inadequate, This
factor is Intended to account for tne uncertainty In extrapolating
animal data to the cast of humans. [IDA]
Use an additional 10-fold factor when extrapolating from less than
chronic results on experimental animals when there H no useful
long-term human data. Tftls factor 1s* Intended to account for the
uncertainty in extrapolating from less than chronic MQAELs to chronic
NQAIis. [105]
Use an additional 10-fold factor when deriving an RfO from a IQAEL
instead of a NOAIL, This factor 1s Intended to account for the
uncertainty In extrapolating from IQAils to liQMls. [lOL]
Modifying Factor {«)
Use professional Judgment to determine another uncertainty factor
(Mf) that is greater than zero and less than or equal to 10. The
magnitude of the NF depends upon the professional assessment of
scientific uncertainties of the study and data base not explicitly
treated at>o¥t, e.g., the completeness of the overall data case and
the nuiaoer of species tested. The default valye for the w Hi,
If the investigator feels that a modifying factor should be used, he is
instructed to get in touch *Hh the appropriate IP* contact for clarification.
-9-
-------
REFERENCES
References elttd 1n the document are to be complete and follow a standard
format. When citing primary data given In a secondary or review document the
original citation must be given along *1th the secondary source (I.e.. Stair
et al., 1978,-as cited Mi U.S. EPA, 1986). The appropriate format for the
citation tn the olbllograpny H as follows:
iansal, Q •«.£-. 19S3. Adsorption of oxamyl and dlmtcron In «»ontmorm§n1te
suspensions. Son Sci, Sac. Am. J. 47:887-882.
U.S. £PA» "1969. Thirteen week feeding study - dog. Project 1210-239, Ace.
i§69!0. OctoDer, Office of Toxic Substances, Washington, 0,C.
U.S. EPA. 1986. Guidelines for carcinogen risk assessment. Federal Register
5U185):339I2-34003,
,10-
-------
Office of *ater
Aqyatic Life and Hyman Health Advisories
I , Executive Sunmary
II. Introduction
III. General Information
A. eStemkal and Physical Properties
B. Occurrence
C. Environmental Fate
Q. Analytical Methods
I, Treatment .' <
f , Human Exposure
IV. Aquitlc Toxldty
A. Introduction
8. Freshwater Toxlclty
C. Saltwater ToxlcHy
0. Quantification of Toxlcologlcal Effects
£. Selected Data Table
V. Manflillan ToxUHy
A. Pharmacoklnttlcs
1. A6$orpt1on
?. Distribution
3. Metabolism
4. Ixcretlon (f 11ml nit ton)
8, Health Effects -
1, Short-Ttrro ixposure
2. Oernwl/Ocylif Efftct?
3. longer -Ttrm Exposure
4. Reproductive Effects
5. Developmental Effects
b. Hutagenlclty
7, CarclnogenlcHy
8. Other Effects
VI. Quantification of ToxlcolofUal Effects
A, Htmn Health
1, water Exposure
a, 1-day HA (for drinking water)
b. 10-diy MA (for drinking water)
c. longer-term HA (for drinking water)
d. Lifetime HA (for drinking water, fish and drinking water,
fish)
e. Cancer Risk Assessment (for drinking water, fish and
drinking water, fish)
-------
Vll. Other Criteria and Standards (Including organolepUc data;
V1ILEPA Contacts
1. .Aquatic Life Advisories
2. ' OMnMng Wattr Advisories
IX. References
-------
I. EXECUTIVE
It. GENEiAl INTRODUCTION
[This section of the HA document Is standard IPA "boilerplate" that is
Included verbatim In all such documents. Normally, a typed version of this
section will be Included in the initial package to the author.]
h Advisories that have betn derived In the document should
summarlietf'here as presented in the OWS format]
contaminant and a concise
general, the emphasis of
of various water
III. GENERAL INFORMATION
[This section provides an identification of the
summary of Us physical and chemical properties. In
this section Is on the Identification or characterization
contaminants. It should Include the following information:]
Chemical and Physical Properties
[A list of fundamental physical and chemical properties that may be
useful 1n assessing hazards associated with contaminants of Interest.]
CAS f
CAS name
Chemical formula
Chemical Structure
Molecular weight
Physical state (at 25 degrees C)
* Melting point
* Soiling point
* Vapor pressure (2S degrees C)
* Specific gravity (25 degrees C)
* Water «olubiiUy (2$ deo/tts C)
* Octanol/water partition coefficient (log Kow)
* Taste threshold (water)
* Odor threshold (water)
* Odor threshold (air)
* 8CF (range of 8CF for Illustrative purposes only)
Synonyms
[A list of related names that are applied to tht chemical of interest.]
Occurrence
(A brlif dtscMptlon of tftt common uses and application of the substances
of inttrtit along with an Indication of th* amount of the substance that the
public could bt exposed to, especially those that Itad to contamination of
ambient and drinking water.]
-13-
-------
Environmental Fate and Human Exposure
[A brief description summarizing the current Information on the transport,
fate, and distribution of the substance 1ft the environment. This section'
should allow * relative source contribution determination,]
IV. AQUATIC TOXICITY
This "4ftt1on will be provided by the EPA,
V. PHAftMACQklNlTICS
[This section should be brief {even If the technical literature is
extensive In this area). The pharmaeoklnetles data may provide supporting
evidence of the quality or relevance of the selected toxlclty data. This
section Is divided Into fo«r subheadings, the contents of which are detailed
below.]
Absorption
[This section should present data that provide a quantitative estimate of
the fraction of an oral dose that Is absorbed from the G! traet Into the body
and for Inhalation, if the chemical 1s volatile, and dermal, even If the
chemical Is or 1s not absorbed through the skin. Data regarding the time
course of absorption should be presented, but should not be confused with the
contents of the section on excretion.]
Distribution
[This section should provide data regarding tissue uptake of the
substance, with special reference to the question of whether any preferential
accumulation In a target organ occurs. To this end, results expressed as
(amount substance)/g tissue) are preferred to those that express results as
total amount of substance In each tissue, although both are useful.]
Metabolism
(This section should focus on covalent reactions that the substance
undergoes in the body, with special enzymatic reactions (activation,
conjugation, etc.) and non-eniymatlc ones (oxidation, hydrolysis, etc.).
Where relevant, noncovalent reactions (binding, adsorption) should also be
covered, ]
Excretjo_n
[Thlt stctlon should provide quantitative data regarding the percent of a
dose that Is eacreted from the body via feces, urine, bile, expired air or
sweat. Half-lift data need to be included in appropriate sections to provide
sense of 'residence tides" with continuous or Intermittent exposures.]
-14-
-------
Vl. HEALTH EFFECTS
[This section Is the west Important part of the document, since H is
from these studies that tht quantitative assessment of risk (section V) Is
made. Since *any substances show cumulative effects, studies {or individual
experiments from more extensive studies) are organized according to the
duration of exposure. Each study discussed should bt well explained providing
Information on dose, exposure concentration, duration and route of exposure
and spedl* differences that are seen in the available results.]
{Human and animal dlta shall be described In separate sections with the -
human data presented first, Additional subheadings should be Included in tnls
section of the document to discuss the available Information on systemic
toxldty {as » function of short and long-term exposure time)
reproductive/developmental toxlclty, teratogenlclty, mMtagen1.c1ty, and
carclnoftnicKy. The contents of these headings and subheadings are discussed
below. When there are no data concerning any of these toxic effects, a
general statement should be made to that effect.]
Human
(Much of the data on human exposure are derived from clinical case
studies and epldemlologle studies. These studies should be briefly summarized
with critical effects Identified.J
Short-Term Exposure (Acute Exposure^ •
[Studies involving a single acute exposure or multiple exposure up to 30
days are Included In this section. Adverse effects on various tissues and
organ systems (e.g., hepatic effects, renal effects, etc.) are presented,) *
Long-Term Exposure (Supchronlc and Chronic Exposures!
[Studies presented ^1n this section involve exposure periods In excess of
30 days. Effects reported are those other than reproductive/developmental.
mutagenic and carcinogenic responses. If there 1s evidence for or against
occurrence of these endpolnts. they should be described under the specific
subheadings.
Animals
Short-Term Exposure (J*cut_e Exposure)
[Studies Involving a single acute exposure (Including LD$QS,
etc.) or multiple exposures up to 30 days are presented. Studies
demonstrating adverse effects on tissues or organ systems (e.g., hepatic
effects, filial effects, etc.) is well as Irritant properties are presented.
Data presented In these studies (other than lethality) serve as the basis for
deriving 1-day and 10-day HAs.]
-15-
-------
Dermal/Ocular Exposure
[This section should contain descriptions of data on eye and s*in
Irritation and shin sensltUatlon, If available. Expectation of systemic
toxlclty following dermal exposure, if different only by degree, should &e
addressed in "the section on Pharmacotnnetles: Absorption.]
longer-Term Ixposure (SubchrpnU and Chronic Ixposures)
[Studies presented in this section Involve long-term exposure (from 30
days up to-It months) or lifetime (2* months for rats or mice). Effects
reported are t"hose organ system effects other than reproductive,
developmental, mutagenlc and carcinogenic responses, fyrther, the effect that
1s tht most appropriate as an Index of chronic toxtcUy should be identified.
Data presented 1n the studies included In this section will usually be used in
deriving the longer-term and lifetime HAS.]
Reproductive Effects
[This section should contain data describing the effects of the substance
on the reproductive success of exposed parents and on the survival of
offspring. This section should also Include data regarding any Increased
frequency in structural anomalies 1n offspring. Scientific guidelines to be
followed are given In FR Sl{185);34027.]
HutagenlcUy
[This section should contain the results of experiments designed to
assess the mutagenlc potential of the substance. Commonly, results from tests
1n bacterial systems (such as the Ames test) will be reported In this section.
as well as various In vitro tests In eukaryotlc cells. Scientific guidelines
to be followed are given in FR Si (18S):3400S.]
CarclnoqenlcUy
[This section should contain the results of experiments designed to
assess the potential,of selected chemicals of Interest to produce tumors in
the various organs/systems. Scientific guidelines to be followed are given 1n
FR 51 (185);33I92 U.S. EM. 198$.]
Other Effects
[If any other p*rt1ntnt Information is detected In the literature, it
should be presented htrt. For example, syntrglstle or antagonistic effects
with other compounds May bt summarized.]
-16-
-------
VI
iUf* Of iQXiCULQGICAL EFFECTS
Health Advisories are based upon the Identification of adverse health
effects associated with the most sensitive nonearclnogenlc endpolnt of
toxlclty, The/ Induction of thH/thesi effeetU) 1s/are related to a
particular exposure dose regime over a specified period of time. The effect
1s usually determined from an animal lexicological study. Standardized risk
character ization methodology for threshold toxicants Is applied In HA
development. The general formula Is is follows:
HA
JNOAEl) (8W)
where; NQAfl
I OAR
BM
UF(S)
_i/day
1 -day Health Advisory
jng/1 (_»g/i)
No-Observed-Advtrse-iffect Level
or
lowtst-Observed-Adverse Effect Level
(the exposure dose In mg/kg bw/day}
assumed body weight of protected Individual
OO-fcg fof cnlld or 70 kg for an atfult)
uncertainty factor, chosen using U.S. IPA, 1986a
guidelines to compensate the uncertainty of NOAU
extrapolations from animal/human studies to human
populations taking Into consideration the amount,
type, and nature of the data
assumed dally water consumption (1 i/chUd: 2
t/aduit)
Tne study by
the 10-kg child 1-day MA
Factors to be consldertd
period, age of test animals
measured, experimental
Interactions
has been selected to serve as the basis for
because-..{add reasons why this study was selected.
Include appropriateness of exposure route, exposure
(or humans), sensitivity of the parameter
limitations, etc. High risk populations, chemical
beneficial effects and other special considerations should also
be Included, as
calculation.}
appropriate. In the selection of studies and/or the
-17-
-------
The i-day HA for ins 10 kg chHd U calculate as follows:
(KOAEt) (10 kg)
l-day HA
where:
NOAEL
UF
(l I/day) (UP)
= based on absence of [effect] In [species] exposed to
[substance] via [route] for [duration]
10 kg » assumed, weight of child
1 i/day ' * assumed water consumption'by a 10 kg child.
uncertainty factor; chosen m accordance with U.S.
EPA, 19861 guidelines
(a)In this case and in all other calculations below, if a lOAEl Is employed,
the test should read; * w
-------
Longer-Term Health Advisory
The study &y
Has been selected to serve as the oasH for
the longer-tefin HA because,...[add reasons why this study was selected]
The longer-terra HA for the 10-kg child is calculated as follows:
LOfger-term HA • (KQAEL i (10 kg) *
when:,
NQAfl
10 kf
UF
1 I/day
{UF) {1 t/day)
a (in ug/kg/ assumed dally water consumption by an adult
lifetime Health Advisory
The lifetime HA represents that portion of an Individual's total exposure that
is attributed to drinking water and 1s considered protective of noncarclno-
genlc adverse health effects over a lifetime eiposure. The lifetime MA 1s
derived In a three step process. Step 1 determines the Reference Dose (RfD),
formerly called the Acceptable Dally Intake (ADI). The RfD Is an estimate
(with uncertainty spanning perhaps an order of magnitude) of a dally exposure
to the human population (including sensitive subgroups) that 1s likely to be
without appreciable risk of deleterious health effects during a lifetime, and
Is derived from the HOAH (or IQAIL). Identified from a chronic
-19-
-------
(or subehronlc) study, divided by an uncertainty faetor{s) times a modifying
factor. From the. SfO, a Drinking later Equivalent Level (OWil) can be
determined (S.tep_*2), A OWEL is a medium-specific (i.e., drinking water)
lifetime exposure level, assuming 100% exposure from that nwdlum, at which
adverse, nonearclnogenlc health effects would not be expected to occur. The
QWEL is der1j|fd from the multiplication of the RfD by the assumed body weight
of an adult Hd divided by tht assumed dally water consumption of an adult,
Tht Ilfet1ro*?ttt In drinking water ilone is determined In Step 3 by factoring
in other source's >f exposure, the relative source contribution (ISC). The RSC
from drinking water is based on actual exposure data or, if data are not
available, a value of 20% is assumed for synthetic organic chemicals and a
value of 10% Is assumed -for Inorganic chemicals. If me contaminant 1s
classified as a Group A or 8 carcinogen, according to the Agency's
classification scheme of carcinogenic potential (U.S. EPA. Ii86b) then caution
should be exercised in assessing the risks associated with lifetime exposure
to this chemical,
The study by _ . _ has been selected to serve as tht basis for the
lifetime HA because ...(state reasons as to why study was selected}.
Using this study the lifetime HA Is derived as follows:
Step 1: Determination of the Reference Dose (RfD)
RfD » NOAEL (of LOMU mg/kq/dav » _ rag/kg/day
UF(s) x Hf
where;
NQAEl -- (or LOAEL) U based on the absence of [effect] in
[species] exposed to [substance] via [route] for
[duration].
UF - 10, 100, 1000, or 10,000 according to U.S. EPA, 1986a
guidelines
«f * Modifying factor >0 to <1
Step 2: Determination of tht Drinking W*.ter Level (DHfl)
OWEL . (JtfD) x 70 kg . _ nig/i (
(2 I/day)
where:
RfD » is given pf/kg/day
70 kg > body weight of protected individual
2 l/day = Assumed dally water consumption by an adult
-20-
-------
Step 3: Determination of lifetime HA for drinking water only
Lifetime HA • OHR X RSC - _ mg/t ( _ wg/i)
where; .'
RSC = Relative Source Contribution (10% or 20% unless
more Information Is available that allows more
concise determinations)
If the available data provide information on the exposure potential from Hsh
along wHh the*bioconcentrat1on factors involved, the author win also
calculate a health advisory for ambient water. This approach allows one to
calculate the lifetime acceptable concentration In ambient water based on
intake resulting from the consumption of nsh only (consumed at i rate of
0,0065 kg/day) and that contributed by the consumption of fish plus irtgestlon
of potable water (2 i/day).
The two procedures are described as follows;
a, fish Only
HA * (RfD (BW) _
(BCF)(fish consumption)
b. Fish plus potable water
HA « (RfQ (SH) _
2 I/day * (BCF) (fish Consumption)
BM * body weight (70 Kg/adult)
BCF * Hoconcentratlon factor (to be supplied)
2 I/day = water consumed per adult/day
flsn consumption * 0.0065 kg/day
Depending upon the amount of data available, a relative source contribution
may also be utilized lo further refine the HA calculated abovt. This is done
my multiplying the final number by the percentage assumed to be contributed by
ambient water. The assumptions used In these calculations must be thoroughly
documented.
Cancer B 1 sjt Asset sgent
[The HA document author Is not required to develop the actual quantitative
carcinogenic risk assessment. However the author will report to the EPA any
data that can be used in the risk assessment calculations by the EPA. from
these data, the IPA can determine the concentration of the chenlcal in
-21-
-------
water (mg/i) that U equivalent to the exposure (mg/kg/day) for each excess
cancer risk level (10*. 10"*, 10"*). The basic assumption used as well
as the general procedures followed In the determination of these risk levels
should accompany the final rtsylts. If there are no carcinogenic data
available, a negative statement to that effect should be made. If the chemical
has been classified by |PA or IARC (EPA 1s preferred) then the boiler plate
caveats stating the chemical's classification should b* included. The IPA
reference to use is U.S. EPA, 19S6b.
VII, OTHEK,CRITERIA, GUIDANCE AND STANDARDS
[IMefly summarize any existing guidelines by EPA, National Institute for
Occupational Safety aed Health (NlOSH)/Qccupat1onal -Safety and Health
Administration (QSHA), Food and Drug Administration (FQA), other Federal
agencies, states and/or foreign nations. Including organoleptlc data. Also
summarize any guidelines promulgated by the National Academy of Sciences
(MAS), world Health Organization (WHO), etc,]
VI11. EPA CONTACTS
A. AQUATIC LIFE ADVISORIES
For further Information regarding the aquatic life and fHh and water
exposure advisories contact:
..__., FTS 47S-7315 (202)475-7315
.__.__. FTS 475-7315 (202)475-7315
I. DRINKING WATER ADVISORIES
For further Information regarding the drinking water human health
advisories contact;
(202J382-
(202)382-
IX, REFERENCES
(This section contains a listing of all references cited In the HA docyment In
the proper format.
NAS (National Academy of Sciences). 1977. Drinking Water and Health. Vol. l,
p. 19-63.
NAS (National Acadtffly of Sciences). liBO. Drinking Water and Health, vol. 3,
p. 25-67,
-22-
-------
u,S. EPA. I986a, Appendix A. Reference Dose (RfD): Description ana use \n
HeaHn Risk Assessment. Integrated Risk Information System (IRIS). Online.
Office of Health and Environmental Assessment, Environmental Criteria
Assessment Office. Cincinnati, OH,
U.S. EPA. 1*86b. Guidelines for Carcinogen Risk Assessment. Federal
Register 51(18$);3399J-34QQ3.
-23-
------- |